Avoiding FDA Pitfalls: Red Flags & Success Factors in Med Tech | The LENKER Podcast with Mark DuVal

In our first episode, hosts John and Kevin dive deep into the world of Med Tech with industry expert Mark DuVal. With over 30 years of experience and more than 1,340 clients at his boutique law firm in Minneapolis, Mark shares invaluable insights on navigating FDA challenges and achieving regulatory success.
Key discussion points include:
The evolution of the FDA's regulatory ecosystem and its impact on Med Tech startups
Common challenges Med Tech startups face when dealing with the FDA
The importance of early and strategic communication with the FDA
The common characteristics of successful (and not so successful) Med Tech companies
The significance of assembling a strong team and leadership to navigate FDA requirements - and who that team should be
Strategies for avoiding common FDA pitfalls and ensuring regulatory success.
Whether you're a seasoned entrepreneur or just starting in the Med Tech field, this episode offers expert advice on overcoming FDA barriers and seizing opportunities in this dynamic industry. It’s relevant to anyone in and around the industry.